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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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products (VMP) regulation The Veterinary Medicinal Products Regulation (EU) 2019/6 is valid from 28 Jan. 2022. It replaces Directive 2001/82/EC and Regulation (EC) 1234/2008 (as far as Tierarzneimittel (TAMs)
an ongoing shortage notification? With the amendment of the Austrian Medicines Act of February 14, 2022 and the associated change to Section 21 (2), the BASG must be notified of a temporary or permanent [...] four months (instead of two months previously) in advance (see also the message in brief of Feb 14, 2022 ). The notification must (as previously) be submitted via the eServices and published by the BASG
2017/745 07/03/2022 Document: Guideline for the classification of change requests | 222 KB Guidance for classification and reporting of amendments during the clinical investigation 07/03/2022 Form: Changes [...] Regulation (EU) 2017/745 25/02/2022 Form: Changes with relevance for monitoring | 91 KB Changes to the investigation with significance for the regulatory oversight 25/02/2022 Form: Security measures, suspension [...] (EU) 2017/745 25/02/2022 Form: Termination notification | 44 KB Notification of completion of a clinical investigation according to Article 77 of Regulation (EU) 2017/745 25/02/2022 SAE Reporting Form |
Code of Conduct applies to the employees of the Austrian Medicines and Medical Devices Agency 10/05/2022 Strategic objectives 1. Ensuring sustainable and successful positioning on the market and within the
Data provision medicine shortages Update March 2022 In order to enable a simple integration of current contents of the „Shortages catalogue“ into external IT systems, two endpoints are provided in a pilot [...] REST-based API retrieval options is already being planned and is expected to be completed from Q2/2022. Release Notes The data file is created daily (between 0:00 and 4:00 am) and made available on the
sheet for users of genetic resources including checklist | 165 KB 07/02/2022 Leitfaden inkl. Annex I und II | 1 MB 07/02/2022
Communication (DHPC) / Educational Material (EM) (L_Z100) | 325 KB Available in German only 03/02/2022
Renewal Applications according to § 20 AMG PSUR Formular: PSUR Zyklusänderungen (F_B23) | 97 KB 24/11/2022
delineation of medicinal products (German only) Form: application for delineation (F_I612) | 92 KB 16/11/2022 Delineation Advisory Board The Delineation Advisory Board (AGBR) is an organ established at the Federal
tion MDCG 2020-16 .. IVDs - Classification MDCG 2021-24 ... Medical devices - Classification MDCG 2022-5 ... Medical Devices - Pharmaceuticals Borderline Manual Old regulations: MEDDEV 2.1/3 ... Delimitation